Kornimate/medical-research-clean huggingface dataset:
long-term safety study of alogliptin used in combination with sulfonylurea or metformin in participants with type 2 diabetes in japan

Conditions: Type 2 Diabetes Mellitus

Summary: to evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (qd), twice daily (bid) or three times daily (tid).

both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. takeda is developing syr-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. alogliptin is an inhibitor of the dipeptidyl peptidase iv (dpp-iv) enzyme. dpp-iv is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. it is expected that inhibition of dpp-iv will improve glycemic control in patients with type 2 diabetes. this was a phase 2/3, multicenter, open-label study, in participants who had completed the core phase 2/3 sulfonylurea add-on study (syr-322/cct-005; nct01318083) or the core phase 2/3 metformin add-on study (syr-322/cct-006; nct01318109) to evaluate the safety and efficacy of alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).

Eligibility criteria:
inclusion criteria: common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study: 1. had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study. 2. was capable of understanding and complying with protocol requirements. 3. signed a written informed consent form prior to the initiation of any study procedure. exclusion criteria: common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study: 1. with clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study). 2. with clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study). 3. with serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission). criteria that applied only to participants completing the core phase 2/3 metformin add-on study: 1. with history or symptoms of lactic acidosis.

Keywords: diabetes mellitus - type 2 diabetes mellitus drug therapy
effect of virtual reality on balance in autism

Conditions: Autism

Summary: children with asd have poorer postural balance when compared to normal individuals. so, the aim of this study is to assess the effect of virtual reality on postural control in autistic children

autism spectrum disorders are a collection of persistent neurodevelopmental disorders characterized by difficulties in social interactions, communication, and repetitive, stereotyped, and restricting behaviors. movement problems can occur throughout infancy and are one of the early indications of autism. furthermore, movement impairments are the most often observed nonverbal deficits in autistic children. postural stability is described as the capacity to maintain an upright posture by keeping the body's center of gravity over its base of support with little swaying or maximal steadiness, and it is considered a fundamental skill required for normal motor development. virtual reality has been used in the field of balance rehabilitation and training because of its relatively low cost and enjoyment. therefore, the purpose of this study was to study the effect of vr on balance in children with asd.

Eligibility criteria:
inclusion criteria: * mild asd exclusion criteria: * taking medication affect motor * had a head injury, genetic disorder, blindness, fracture

Keywords: autism spectrum disorder biodex postural control virtual reality
oxynorm capsules in post-operative pain study

Conditions: Postoperative Pain

Summary: the efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.

to evaluate the efficacy and safety of oxycodone immediate-release capsules compared with morphine immediate-release tablets in hospitalized patients with moderate to severe pain following surgery.

Eligibility criteria:
inclusion criteria: 1. patients of either sex aged 18 to 80 years inclusive. 2. patients who have given written informed consent to participate in the study. 3. able and willing to communicate with the investigator and his/her staff. 4. free of anesthesia as assessed through question and answer interaction with nurse at which time oral medication is indicated. 5. reporting "moderate" or "severe" pain (vas ≥ 4) related to surgery and requesting analgesics for pain relief. exclusion criteria: 1. patients have developed tolerance to or dependence on narcotic analgesics and/or alcohol. 2. patients with asa ≥ 3 . 3. have any concomitant medical condition that would be adversely affected by analgesics or confound the quantification of analgesia, or could affect the absorption, metabolism or excretion of the study drugs in any clinically significant fashion. 4. have known hypersensitivity to any of the study medications or related agents. 5. have taken analgesic medications within three hours (wash-out) prior to dosing. 6. have developed complications from the surgical procedure that would confound the study. 7. have a history of severe iatrogenic adverse experiences. 8. mothers nursing their infant during the 24 hours following study drug administration, or pregnant women. 9. patient with nothing per os (npo) as stated in patient's chart or physician's order. 10. surgery in patients with epidural anesthesia 11. patients with severe impairment of liver at preoperative stage (alt, ast ≥ 1.5 times upper limit) and abnormal renal function. 12. patients with medical history of recovering from abnormal surgery anesthesia. 13. patients with medical history of hypertension (systolic blood pressure ≥ 180hg, diastolic blood pressure 110hg). 14. patients with shock. 15. patients with copd. 16. according to investigator to determine, patients are in addition the inclusion criteria and exclusion criteria for any other reason than not suitable in this study.
premenstrual dysphoric disorder and antiepileptic drugs

Conditions: Epilepsy

Summary: this study is being done to determine if there are differences in mood during the menstrual cycle among women with epilepsy who take various different antiepileptic drugs and women without epilepsy.

participants will be given informed consent during the initial study visit. we will gather information about their seizure disorder and medications and provide them with instructions and a form that they will complete daily for two months (two menstrual cycles). during the third week of each menstrual cycle, they will be asked to return once to provide a blood sample.

Eligibility criteria:
inclusion criteria: * women with epilepsy, 18-45 years of age. women will be on one of 4 established (≥ 3 months) aed monotherapies: ltg, cbz, pht or lev and with documented therapeutic range serum aed level during the year prior to enrollment. * normal control women, 18-45 years of age, in good general health by history exclusion criteria: * concomitant use of prescribed or otc reproductive hormones * concomitant use of antidepressant and anxiolytic medications such as ssris, bupropion, tricyclics, benzodiazepines

Keywords: epilepsy lamotrigine levetiracetam carbamazepine phenytoin lamictal keppra tegretol carbatrol dilantin
investigation of pain coping methods and related factors in postmenopausal women

Conditions: Pain

Summary: musculoskeletal pain (msp) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. coping strategies with pain are used to manage the pain and its impacts. the present study aimed to compare active and passive coping strategies used and pain severity in postmenopausal women according to their demographic characteristics. also, the relationship between pain and coping strategies in postmenopausal women with cmsp will be examined.

musculoskeletal pain (msp) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. if msp lasts for longer than three months, it becomes chronic. the prevalence of chronic msp (cmsp) increases with aging and its ratio changes between 35,7% and 49,8%. the previous studies demonstrated the differences in the prevalence of cmsp between men and women. according to most of the studies, older women adults are more vulnerable to experience than men due to some differences in perception of pain such as biological characteristics, their roles in daily life, beliefs or coping strategies with pain. oestrogen has a prominent role in the physiology of muscles, tendons, ligaments, and bones. the decline of this sex hormone during menopause transition could lead to msp, particularly in the postmenopausal period. indeed, an increasing rate of cmsp in postmenopausal women has been reported. coping strategies with pain are used to manage the pain and its impacts. coping with pain requires the self-regulation of individuals using cognitive and behavioral reactions. dealing with cmsp is a process that can need the making of changes in daily life and activities this study aimed to compare active and passive coping strategies being used and pain severity in postmenopausal women according to their age, marital status, educational status, and exercise habits. also, subdomains of strategies and subdomains of pain and the relationship between pain and coping strategies in postmenopausal women with cmsp will be examined.

Eligibility criteria:
inclusion criteria: * complaints of pain in anywhere of their body. * presenting at least 1 year of amenorrhea * being between the ages of 50-69 years. exclusion criteria: * have rheumatological, orthopedic and neurological diseases, * have compression fractures, malignancies, * have a chronic disease that will lead to secondary osteoporosis, * have a drug use that will lead to secondary osteoporosis

Keywords: postmenopausal pain coping
comprehensive hand repetation intensive strength training on upper limb in children with cerebral palsy

Conditions: Cerebral Palsy (CP)

Summary: hemiplegia is the medical term for paralysis of one side of the body this means their shoulder; arm, hand, leg and foot are all completely paralyzed.. it results in muscular wasting on the affected side, impairs gait, reduces motor abilities, and causes instability and a loss of grasping capacity. the patient\&#39;s quality of life is impacted by hemiplegia because it impairs brain and spinal cord functions hemiplegic cerebral palsy is the type of cerebral palsy in which there is absolutely no use of one side of the body. this means their shoulder; arm, hand, leg and foot are all completely paralyzed. hemiplegia in infants and children is a type of cerebral palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. this damage may occur before, during or shortly after birth. the term hemiplegia means that the paralysis is on one vertical half of the body.

the comprehensive hand repetitive intensive strength training (christ) program is designed to provides special training for enhancing muscular strength of the upper limb. the current study will be a randomized control trial, and data will be collected from ittefaq hospital lahore pakistan. the study will include 30 patients equally divided into two groups experimental group included 15 patients, and the control group included 15 patients and was randomly allocated. the inclusion criteria for the study will be comprehensive hand repetitive intensive strength training on the upper limb of cp patients with age between 6 to 12 years and both genders will be included children who have normal communication skills and cognitive function will be included and give 30 minutes per session three sessions in a week and total 30 sessions per ten weeks and to normalize muscle tone and patient able to perform adls. children having damaged musculoskeletal system including fracture of upper limb and contracture will be excluded children having undergone administration of medicine influencing muscular strength and spasticity will be excluded tools used for data collection are jebsen-taylor hand function test and abil hand for upper limb and data will be analyzed by spss version 26.

Eligibility criteria:
inclusion criteria: * ages 6 to 12 years will be included * both genders will be included * gmfcs i and ii * children who have normal communication skills and cognitive functions will be included exclusion criteria: * children having damage to the musculoskeletal system including fracture of the upper limb and contracture will be excluded * children who have undergone the administration of medicine influencing muscular strength and spasticity will be excluded

Keywords: cerebral palsy muscle strength upper extremity
adequate bending angle of a lightwand

Conditions: Tracheal Intubation

Summary: for tracheal intubation with a lightwand, adequate bending angle was not exactly investigated. the purpose of the study is compare three bending angles of lightwands for safe and efficient tracheal intubation.

lightwands are very useful device for difficult airway management due to small moth opening, weak teeth, and cervical spine instability. experienced clinicians use a lightwand while bending it adequately. however, there has been not previous studies to investigate the adequate angle to bend it. this randomized controlled trial is to compare three angles (70, 80, and 90 degrees) as bending angle of lightwands for safe and efficient tracheal intubation in cases which require the use of lightwands.

Eligibility criteria:
inclusion criteria: * patients who require use of a lightwand for tracheal tubes (i.e. small mouth opening, weak teeth, cervical spine instability) exclusion criteria: * patients who refuse to participate the study

Keywords: tracheal intubation lightwand
therapeutic exercise and education in pain neurophysiology to improve pain intensity in women with endometriosis. clinical trial.

Conditions: Endometriosis

Summary: the objective of this study will be to evaluate treatment using et exercise and pain education in women with endometriosis to improve pain intensity.

a study will be carried out whose objective is to improve the intensity of pain in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. also as secondary variables will be observed: kinesiophobia, catastrophism and impression of global improvement with treatment.

Eligibility criteria:
inclusion criteria: * women of reproductive age between 18 and 45 years. * women with a medical diagnosis of endometriosis. * women with visual analog scale (eva) between 4 and 10 (moderate-severe pain) during the last 3 months in the suprapubic area, abdomen or perineum both continuously and intermittently. exclusion criteria: * women who must have surgery during the study. * women who have undergone abdominal or pelvic surgery or who have given birth (vaginal or cesarean) in the last 6 months. * women who are pregnant or planning a pregnancy. * women with uncorrected pacemakers or coagulopathies, severe comorbid disorder, cancer (in the last 5 years or at present), severe mental disorders, or neuropathies affecting the nerves of the pelvis or lower extremities. * physiotherapy treatments or treatments related to pathology or study areas 15 days prior to the beginning of the study. * variations in medication in the 3 months prior to the start of the study.

Keywords: pain quality of life chronic pelvic pain therapeutic exercise pain neurophysiology physiotherapy
double-blind, randomized study evaluating the efficacy and safety of brivaracetam in adults with partial onset seizures

Conditions: Epilepsy

Summary: this study will evaluate the efficacy and safety of brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Eligibility criteria:
inclusion criteria: * subjects were from 16 to 70 years, both inclusive. subjects under 18 years of age were only included where legally permitted and ethically accepted * subjects with well-characterized focal epilepsy or epileptic syndrome according to the international league against epilepsy (ilae) classification * subjects had a history of partial onset seizures (pos) whether or not secondarily generalized (type i seizures according to the ilae classification) * subjects had at least 2 pos whether or not secondarily generalized per month during the 3 months preceding visit 1 * subjects had at least 8 pos whether or not secondarily generalized during the 8-week baseline period * subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (aeds). vagal nerve stimulation was allowed and was not counted as a concomitant aed exclusion criteria: * history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before visit 3 * history or presence of status epilepticus during the year preceding visit 1 or during baseline

Keywords: epilepsy brivaracetam partial onset seizures
microparticles in severe aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: microparticles are small cell fragments that can induce fat plaques, calcification and formation of thrombus. they can be released through multiple stimulations, but also the high flow of blood through partially obstructed aortic valves. in patients with severely obstructed aortic valves the investigators hypothesize that microparticles levels will be elevated and that they will go down after percutaneous treatment of the valves.

microparticle (mps) levels and subtypes according to endothelial cell, macrophage and platelet markers will be measured by flow-cytometry using appropriate fluorochromes. patient baseline (including measures of severity of aortic stenosis and its calcification), procedural data, and clinical evolution will be collected. inflammatory markers will be measured, which along with clinical date will be tested for correlation with microparticle levels. patients mps will be measured before and after percutaneous treatment of the severe aortic stenosis.

Eligibility criteria:
inclusion criteria: * clinical indication to be treated with transcatheter aortic valve replacement. exclusion criteria: * non native aortic valve * moderate aortic regurgitation * the following complications following valve implantation: patient instability, need for vasoactive pressors, sepsis and severe infections, stroke.

Keywords: microparticles severe aortic stenosis calcified aortic stenosis transcatheter aortic valve replacement
the comparative study of full-endoscopic cervical posterior discectomy and anterior cervical decompression and fusion

Conditions: M-JOA Score

Summary: anterior cervical decompression and fusion is the standard procedure for operation of cervical disc herniations. mobility-preserving full-endoscopic cervical posterior discectomy is the most common alternative in the case of soft localization of the pathology. endoscopic techniques are considered standard in many areas, since they may offer advantages in surgical technique and rehabilitation. these days, all disc herniations can be operated in full-endoscopic technique. with the full-endoscopic posterior cervical discectomy a procedures is available for cervical disc operations.

investigators conducted a differential, randomized, 1:1, double-blind clinical control trial to compare the clinical effect, safety and feasibility of full-endoscopic cervical posterior discectomy and anterior cervical decompression and fusion. the study was conducted in three centers at the same time, including the second affiliated hospital of zhejiang university medical college, zhejiang provincial people's hospital and ningbo university medical college affiliated hospital. this study is expected to include 308 patients with single level soft cervical disc herniation.participants were randomly assigned to different groups for corresponding surgical intervention after complete preoperative evaluation.participants received a standard 5-year follow-up procedure

Eligibility criteria:
inclusion criteria: 1. single cervical intervertebral dis herniation wih symptoms of radicular pain or spinal cord compression ; 2) the herniated lesions had no obvious calcification; 3) conservative treatment fails ; 4) mild myelopathy (nurick grade 3 or blow. (6) patients agree to participate in this study. exclusion criteria: 1. cervical segmental instability or deformity (cervical spondylolisthesis or cobb angle greater than 25°); 2) multisegmental lesions (≥2); 3) tumor, infection or other unknown space occupying in cervical vertebra; 4) surgical history of the target segment; 5) severe myelopathy (nurick grade 4 or above); 6) the patients were not suitable for surgery, had poor medical management or did not agree to participate in this study.

Keywords: cervical disc herniation endoscope posterior minimally invasive spine surgery
adaptability to stress of healthcare workers in the 8th arrondissement

Conditions: Occupational Stress

Summary: participants will be selected according to their affiliation with the paris 8 cpts. they will be asked to complete a series of self-questionnaires to determine their stress levels and lifestyle habits. these tests will be used to define a wellness pathway for each participant in order to reduce the stress they feel at work. these wellness pathways are based around 4 distinct themes: * diet, nutrition and micronutrition * physical activity * sleep * stress and wellness. participants will be follow-up at 3 and 6 months by means of self-questionnaires and advice on the programme.


Eligibility criteria:
inclusion criteria: * people of legal age * health professionals and players from the cpts paris 8 association: * pharmacist, * doctor * midwife * physiotherapist, * dentist, * nurse, * pharmacy assistant, * dietician-nutritionist, * speech therapist, * chiropodist, * adapted physical activity teacher, * medical secretary, * other health service staff (maintenance, reception, general services and it staff). * persons having given their non-opposition to participate in the study. * persons affiliated to a social security scheme or beneficiaries of such a scheme (article l1121-11) exclusion criteria: * people already following a wellness programme. * people undergoing treatment for stress prescribed by a doctor. * people on sick leave or long-term leave who are no longer at work and who cannot be included in the study. * people with a poor understanding of spoken and/or written french. * vulnerable persons in accordance with article l1121-6 of the csp. * persons subject to a legal protection measure (guardianship, curatorship) or unable to express their consent/non-opposition in accordance with article l1121-8 of the csp or under court protection in accordance with article l1122-2 of the csp.

Keywords: professionals and actors health